Combination Lexapro and Massage for Treatment of Depression in Older Adults

Stopped early · Not applicable

Conditions studied: Depression

In brief

Depression is a common and disabling condition which represents a substantial public health concern, especially with the aging of the population in general. In fact, one to four percent of the older population has major depression. Although medication is the main treatment for depression, studies show that only 50% of patients show a significant response to treatment. The response might actually be less in older subjects, and with more adverse side effects due to changes in the metabolism of the older population as well as drug interaction. For these reasons (changes in metabolism and possible drug interactions) the starting dose of the antidepressant Lexapro will be 5mg, instead of 10mg. To combat the incomplete response to medication, many combined and augmentation strategies have been developed. Examples of this would be an antidepressant medication plus a neuroleptic medication; or an antidepressant medication plus talk therapy. One non-medication treatment that is being considered is massage therapy. Recent data suggest that massage therapy can be useful for the treatment of depression. This study proposes to perform a controlled trail to assess the effects of massage therapy on symptoms of depression in older subjects with major depression. All of the subjects will receive Lexapro, which is an FDA approved medication for the treatment of depression. Half of the subjects will receive Swedish massage for one hour, twice a week, and the other half will receive light touch for one hour, twice per week for eight weeks. Standardized rating scales that evaluate depression will be used to evaluate the subjects mood.

Key facts

Study ID: NCT00643162
Run by: Cedars-Sinai Medical Center
People needed: 17
Starts: 2006-06-01
Expected to finish: 2010-02-01
Last updated by the study team: 2019-06-18

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

> 60 years of age
Unipolar major depression as defined by Structured Clinical Interaction DSM-IV (SCID)
HAM-D score of > 17 (21-item scale)]]
Not taking antidepressants for at least two weeks, 2 months for fluoxetine and MAOIs]]
Capable of giving informed consent.

You may not qualify if…

Unable to provide informed consent (e.g. severe cognitive impairment)
Acute medical condition or exacerbation of chronic medical condition associated with significant distress (pain, protracted fevers, etc.) and requiring active medical treatment.
High risk of suicide or violence as assessed by the investigator
Current or past history of psychosis or bipolar disorder
Use of psychotropic medication and/or psychotherapy outside of the study
(Exposure to treatment of fluoxetine or MAOIs in the previous two months; chronic use of benzodiazepine and non-benzodiazepine sedatives, antipsychotics, psychostimulants, mood stabilizing agents, codeine, steroids, anti-inflammatory agents.
Alternative medicine use in the preceding 30 days (e.g. acupuncture, herbs, etc.)
History of intolerance to massage or contraindication to massage (e.g. skin lesions that prevent direct contact by the therapist)
Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression or bipolar disorders;
MMSE less than 22
Alzheimer's Disease Assessment Scale-Cognitive Subscale ³ greater than 12
Current drug or alcohol abuse or dependence or history of drug or alcohol abuse or dependence within the past 6 months
Unstable medical or neurological conditions that are likely to interfere with the treatment of depression
Currently on psychotropic medications including antidepressants or neuroleptics
Active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study

Where it is running

Cedars-Sinai Medical Center Department of Psychiatry and Behavioral Neurosciences — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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